- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00807339
CyberKnife for Unresectable Renal Tumors
March 20, 2017 updated by: Irving Kaplan, Beth Israel Deaconess Medical Center
CyberKnife Stereotactic Radiation for Unresectable Renal Tumors/PhaseI Study
This is a dose escalation study using the CyberKnife radiotherapy device for small surgical or medically untreatable renal tumors.
Patients with renal tumors 5cms or less in diameter will be accrued onto this study.
The ability of CyberKnife to ablate these renal tumors and maintain renal function with dose escalation will be assessed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy.
The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation.
This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Tumor size 5 cm or less
- Radiographic evidence of malignancy or Histologically verified primary renal malignancy.
- If the kidney biopsy is inconclusive but the radiologist determines that the tumor based on the CT/MRI is highly suspicious for cancer, you may participate
- Patients with highly suspicious lesions on CT or MRI
- One -three gold fiducials placed in or around tumor
- Contradiction or patient refusal to partial or complete nephrectomy
- Age 18 or greater
- KPS score 70 or greater
Exclusion Criteria:
- Irreversible coagulopathies that preclude fiducial placement
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Phase I dose escalation
|
Dose escalation three consecutive treatments
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the maximum tolerated dose of CyberKnife radiation
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate local control, overall survival and late toxicity including preservation of renal function
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2006
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
August 20, 2014
Study Registration Dates
First Submitted
December 10, 2008
First Submitted That Met QC Criteria
December 10, 2008
First Posted (Estimate)
December 11, 2008
Study Record Updates
Last Update Posted (Actual)
March 21, 2017
Last Update Submitted That Met QC Criteria
March 20, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005P00384
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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